Condition category
Mental and Behavioural Disorders
Date applied
05/02/2018
Date assigned
07/02/2018
Last edited
30/05/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Severe mental illness (SMI) such as schizophrenia affects 24 million people worldwide, with costs to society estimated at nearly £12bn in England. It typically starts in early adulthood and up to 80% relapse within 5 years, resulting in unscheduled acute care and adverse effects on psychosocial development. The main treatment for psychosis is medication and psychosocial interventions. Currently, the delivery of psychosocial interventions for psychosis by scheduled appointment can result in indicators of relapse either being missed or treated too late. There is a need for innovative, timely, efficient and cost-effective solutions to improve the speed and quality of recovery in psychosis, over and above conventional drug and psychosocial treatments. The NHS has a clear digital agenda for addressing mental health challenges, aiming to fully harness the information technology revolution, and self-management in long-term conditions is a cornerstone of NHS policy. Smartphones offer an unprecedented opportunity to drive improvements in treatment quality, efficiency, cost, access and facilitate self-management. A user-informed, personalised, smartphone app, Actissist, has been developed which delivers a theory-driven psychological intervention that is unconstrained by traditional service settings. Patients can complete the intervention swiftly in the course of daily life over 12-weeks and this technology is feasible, safe and acceptable. The aim of this study is to refine the software and assess its effectiveness in early psychosis.

Who can participate?
Adults (16 or older) with early psychosis (within 5 years of initial episode) who are in contact with Early Intervention Services or Secondary Care Services

What does the study involve?
Participants are randomly allocated to one of two groups: the treatment group or the control group. Eighty-five people in the treatment group are asked to use the Actissist app on top of their usual treatment, and 85 people are asked to use a symptom monitoring app (ClinTouch) plus their usual care. Before using the apps, participants are asked to complete some questionnaires about their feelings and experiences. Participants also receive a training session on how to use the app and receive weekly telephone calls from a researcher to see how people are getting on with using the app. Participants using the Actissist app also meet with the researcher to set a goal to work towards while using the app. After 12 weeks of using the apps, participants are invited to complete the same questionnaires they filled out at the start of the study and additional questions about how they felt about the app they received. Some participants are interviewed to find out what it was like being involved in the study at the end of the 12-week study period. People who do not wish to take part in the study, but who are interested in providing their views about apps for psychosis, are also interviewed. Mental health care staff are also invited to attend interviews to give their views about the implementation of apps for early psychosis in mental health services. Finally, surveys are given to participants, in addition to service users and staff who are not participants. These surveys can be completed online via a secure website or with paper-based questionnaires. Questions in the survey focus on participants’ technology ownership and their interest in using technology support options for early psychosis.

What are the possible benefits and risks of participating?
It is not known whether the Actissist app will result in improvements. For this reason, participant feedback, views, experiences and input are important to help towards the development of an app that could improve access and choice over treatment options for people with experience of psychosis. Some people also enjoy completing the tasks involved in taking part in research and being given the opportunity to speak with someone about their experiences. Some people may find it difficult to answer questions about their feelings. However, in an early study and in the development of the ClinTouch app, very few people have reported feeling distressed through completing the questions.

Where is the study run from?
The study is being run from the University of Manchester, who are working with various Early Intervention and Secondary Care Services based at trusts across the North West of England

When is the study starting and how long is it expected to run for?
March 2018 to June 2020.

Who is funding the study?
Medical Research Council (MRC) (UK)

Who is the main contact?
1. Dr Sandra Bucci (PI)
sandra.bucci@manchester.ac.uk
2. Dr Alyson Williams (Project Officer)
alyson.williams@manchester.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sandra Bucci

ORCID ID

http://orcid.org/0000-0002-6197-5333

Contact details

Division of Psychology and Mental Health
School of Health Sciences
Zochonis Building
University of Manchester
Brunswick Street
Manchester
M13 9PL
United Kingdom
+44 (0)161 306 0422
sandra.bucci@manchester.ac.uk

Type

Public

Additional contact

Dr Alyson Williams

ORCID ID

Contact details

Division of Psychology and Mental Health
School of Health Sciences
Zochonis Building
University of Manchester
Brunswick Street
Manchester
M13 9PL
United Kingdom
+44 (0)161 306 0428
Alyson.williams@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

36418

Study information

Scientific title

Active Assistance for Psychological Therapy 2.0 (Actissist 2.0): digital intervention for co-producing care in psychosis

Acronym

Study hypothesis

Onset of psychosis typically occurs in early adulthood. Up to 80% relapse within 5-years, resulting in unscheduled acute care and adverse effects on psychosocial development. The main treatment for psychosis is medication and psychosocial interventions. Currently, the delivery of psychosocial interventions for psychosis by scheduled appointment can result in psychosis relapse indicators either being missed or treated too late. The NHS has a clear digital agenda for addressing mental health challenges, aiming to fully harness the information technology revolution. Smartphones offer an unprecedented opportunity to drive improvements in treatment quality, efficiency, cost, access and facilitate self-management. Supported by MRC DPFS funding (MR/L005301/1), we have developed a user-informed, personalised, smartphone app, Actissist, that delivers a theory-driven psychological intervention over 12 weeks that is unconstrained by traditional service settings. We have shown that patients complete the intervention swiftly in the course of daily life over 12-weeks and that this technology is feasible, safe and acceptable.

The primary aim of the current proposal, Actissist 2.0, is to refine the software and conduct an efficacy study in an psychosis group. The randomized controlled trial will be carried out over 36 months and involves an initial period of app refinement, followed by an evaluation of the efficacy and usability of the app in a randomized controlled trial.

Primary hypothesis: participants allocated to the Actissist group will have a lower mean PANSS total score compared to those allocated to the control (symptom monitoring) group at 12 week follow-up (T2)
Secondary hypothesis: participants allocated to the Actissist group will have a higher mean score on secondary outcomes compared to those allocated to the control (symptom monitoring) group (or lower score, if lower indicates improvement on the scale) at 12 week follow-up (T2)

Updated 23/04/2018: The primary outcome will be determined at the 12-week (post randomisation) follow-up timepoint

Ethics approval

Research Ethics Committee 4, West of Scotland, 14/11/2017, ref: 17/WS/0221

Study design

Randomised; Both; Design type: Treatment, Psychological & Behavioural, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Mental health, Primary sub-specialty: Psychosis; UKCRC code/ Disease: Mental Health/ Organic, including symptomatic, mental disorders

Intervention

Participants will be randomly assigned on a 1:1 ratio to either the intervention (Actissist plus TAU) or control (ClinTouch plus TAU) groups.

Actissist intervention: Theoretically-informed content administered via a mobile phone app.
The control group will receive ClinTouch, which is a mobile phone application developed to monitor mood and symptoms of psychosis (Palmier-Claus et al., 2012).

Intervention length: 12 weeks; Follow-up: 12 weeks post randomisation and 24 weeks post randomisation; Study Entry: Single Randomisation only.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Psychotic symptoms are measured using the Positive and Negative Syndrome Scale (PANSS) at baseline, 12 weeks post randomisation and 24 weeks post randomisation

Updated 23/04/2018: The primary outcome will be determined at the 12-week (post-randomisation) follow-up timepoint

Secondary outcome measures

All outcomes measured at baseline, 12 weeks post randomisation, and 24 weeks post randomisation:

1. Symptom distress is measured using the Psychotic Symptoms Rating Scales (PSYRATS)
2. Mood is measured using the Calgary Depression Scale (CDSS) for Schizophrenia
3. Social functioning is measured using the Personal and Social Performance Scale (PSP)
4. Perceived criticism and perceived warmth is measured using the Perceived Criticism and Perceived Warmth Scale (PCPW)
5. Recovery is measured using the Questionnaire about the Process of Recovery (QPR)
6. Well-being is measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWEBS)
7. Internalised stigma is measured using the Internalised Stigma of Mental Illness Inventory (ISMI)
8. Cannabis use frequency is measured using the Time Line Follow Back for drugs and alcohol (TLFB) and the DUDIT/DUDIT-E
9. Empowerment is measured using the Empowerment Scale (ERS)
10. Health economics is measured using Euro-Qol Five Dimension (EQ-5D-5L) and Client Service Receipt Inventory (CSRI)

Updated 20/03/2018:
8. Substance use is measured using the Alcohol Use Disorders Inventory (AUDIT; past 3 months), Cannabis Use Disorders Inventory-Revised (CUDIT-R; past 3 months), Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), Drug Use Disorder Identification Test-Extended (cannabis only). Cannabis use frequency is measured using the Time Line Follow Back for drugs and alcohol (TLFB)

Overall trial start date

01/10/2017

Overall trial end date

30/09/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 20/03/2018:
1. Meet ICD-10 criteria for a schizophrenia-spectrum diagnosis (ICD codes F20, F22, F23, F25, F28, F29) as confirmed by the treating clinician or Early Intervention for Psychosis Service entry criteria, operationally defined using the Positive and Negative Syndrome Scale (PANSS) and/or the psychosis transition criteria of the Comprehensive Assessment of At-Risk Mental States
2. In contact with mental health services
3. Within 5 years from onset of first psychotic episode, deemed by the treating clinician
4. Meet a criterion level of positive symptoms severity, indicated by a score of >3 (symptom present) on any PANSS positive item and a score of >3 (symptom present) on any PANSS negative or PANSS general items
5. English speaking
6. Aged 16 years or older
7. Capacity and willingness to provide informed consent
8. Not currently participating in another trial

Previous inclusion criteria:
1. Early psychosis (within 5 years of initial episode), deemed by the treating clinician
2. In current contact with either an early intervention service or a secondary mental health service
3. PANSS total score 65 or more
4. English speaking
5. Aged 16 years or older
6. Capacity to provide informed consent
7. Not currently participating in another trial

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 170; UK Sample Size: 170

Participant exclusion criteria

Current inclusion criteria as of 20/03/2018:
1. Anyone with psychosis not in contact with a NHS mental health service
2. Anyone less than 16 years old at the point of recruitment
3. Anyone not capable of giving informed consent
4. Non-English proficient
5. Score <3 on all PANSS positive, negative and general items

Previous inclusion criteria:
1. Anyone with psychosis not in contact with a NHS mental health service
2. Anyone less than 16 years old at the point of recruitment
3. Anyone not capable of giving informed consent
4. Non-English proficient
5. Score <65 on PANSS total
6. Current participation in another trial

Recruitment start date

16/02/2018

Recruitment end date

30/09/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Greater Manchester Mental Health NHS Foundation Trust (Lead Centre)
Bury New Road Prestwich
Manchester
M25 3BL

Trial participating centre

Bolton Early Intervention Service
Bentley House Viking Works Weston Street
Bolton
BL3 2RX

Trial participating centre

Bolton North Function Team
Bentley and Barnett House Viking Works Weston Street
Bolton
BL3 2RX

Trial participating centre

Bolton South Function Team
Barnett House Viking Works Weston Street
Bolton
BL3 2RX

Trial participating centre

Salford Early Intervention Team
Broadwalk Centre 51 Belvedere Road
Salford
M6 5EJ

Trial participating centre

Cromwell House CMHT
Cromwell Road Eccles
Salford
M30 0GT

Trial participating centre

Prescott House CMHT
Little Hulton
Salford
M28 0ZA

Trial participating centre

Ramsgate House CMHT
Ramsgate Street Lower Broughton
Salford
M7 2YL

Trial participating centre

Trafford Early Intervention Service
Crossgate House Cross Street
Sale
M33 7FT

Trial participating centre

Trafford - North CMHT
Crossgate House Cross Street
Sale
M33 7FT

Trial participating centre

Trafford – South CMHT
2A Craven Drive Brook Heys Broadheath
Altrincham
WA14 5JF

Trial participating centre

North Manchester Early Intervention Service
Wilson’s Park Monsall Road
M40 8WN

Trial participating centre

South Manchester Early Intervention Service
Wilson’s Park Monsall Road
M40 8WN

Trial participating centre

Manchester – North West Area Team CMHT
Macartney House Beech Mount
Harpurhey
M9 5XS

Trial participating centre

Manchester – North East Area Team CMHT
Moston Lane Harpurhey District Offices
M9 4AD

Trial participating centre

Manchester – Central West Area Team
Kath Locke Centre 123 Moss Lane East
M15 5DD

Trial participating centre

Manchester – Central East Area Team
Rawnsley Building Manchester Royal Infirmary
M13 9WL

Trial participating centre

Manchester – North Mersey Area Team
Kingslea House Francis Road
Withington
M20 4XP

Trial participating centre

Manchester – South Mersey Area Team
Brian Hore Unit
West Didsbury
M20 2LR

Trial participating centre

Pennine Care NHS Foundation Trust
225 Old Street
Ashton-Under-Lyne
OL6 7SR

Trial participating centre

Oldham Early Intervention Team
5 Waterloo Street
Oldham
OL1 1 SP

Trial participating centre

West Oldham CMHT
Maple House Hamilton Street
Oldham
OL4 1DB

Trial participating centre

East Oldham CMHT
Maple House Hamilton Street
Oldham
OL4 1DB

Trial participating centre

Bury Early Intervention Service
Humphrey House Angouleme Way
Bury
BL9 0BQ

Trial participating centre

Bury CMHT
Humphrey House 4 Angouleme Way
Bury
BL9 0BQ

Trial participating centre

Heywood, Middleton & Rochdale Early Intervention Service
John Elliot Unit Birch Hill Hospital
Rochdale
OL12 9QB

Trial participating centre

Heywood, Middleton & Rochdale CMHT
Hanson Corner Hanson Street
Middleton
M24 2HW

Trial participating centre

Stockport Early Intervention Service
Councillor Lane Resource Centre Councillor Lane
Cheadle
SK8 2JF

Trial participating centre

Sector 1 Stockport CMHT
21 Heaton Moor Road York House
Stockport
SK4 4LT

Trial participating centre

Sector 2 Stockport CMHT
Councillor Lane Resource Centre Councillor Lane
Cheadle
SK8 2JF

Trial participating centre

Tameside and Glossop Early Intervention Team
225 Old Street
Ashton-under-Lyne
OL6 7SR

Trial participating centre

Tameside South CMHT
Outram Road
Dunkinfield
SK16 4XE

Trial participating centre

Tameside North CMHT
Haughton House Stamford Street East
Ashton-Under-Lyne
OL6 6QQ

Sponsor information

Organisation

The University of Manchester

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The study protocol is in the process of being prepared for publication. The study protocol will be made available once published. Planned publication of the study results in a high impact peer-reviewed journal, with the intent to submit the outcome paper for publication January 2021. Planned presentations at public engagement events and national and international conferences, presenting to audiences working in the field of psychosis and/or technology.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/01/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

30/05/2018: Internal review. 23/04/2018: The study hypothesis and primary outcome measure were updated. 20/03/2018: The secondary outcome measures, inclusion and exclusion criteria were updated.